Supplementary Protection Certificates Handbook

Description

Supplementary Protection Certificates are of great importance to the pharmaceutical industry as a method of increasing the length of market exclusivity for successful medicines to compensate for delays in marketing a product which results from compliance with the regulatory requirements.

Providing a comprehensive commentary to the Supplementary Protection Certifcate Regulations (the SPC Regulations), this practical handbook highlights the various issues and uncertainties in the SPC Regulations which have not only been illustrated by EU wide case law but by cases which currently remain undetermined. The invaluable analysis provided by this work enables practitioners to make informed and strategic decisions in relation to these important rights, whether they are involved in the application and grant of these rights or their enforcement. The work provides the relevant background to the SPC Regulations in order to define their underlying purpose and to analyse problematic elements of this, before going on to provide an EU wide commentary on the individual provisions of the SPC Regulations.

Supplementary Protection Certificates Handbook

Table of Contents

1. Introduction2. The Origins of the SPC Regulations and Interpretation3. The Fundamental Tenets of the SPC Regulations and Their Impact4. Other Definitions and Terms5. Obtaining an SPC6. Scope of Protection and Infringement7. Formalities in an SPC Application, Entitlement and Grant8. Duration of the SPC, Expiry and Revival9. Invalidity10. The Transitional Provisions11. Paediatric Extensions12. Plant Protection Certificates13. Patent Extensions Outside of EuropeAppendices

Supplementary Protection Certificates Handbook

Author Information

Daniel Alexander is a QC at 8 New Square. With over 20 years' experience of litigation and advice in intellectual property cases, his practice covers all areas of intellectual property. Cases have involved medical and plant biotechnology (including SPCs), pharmaceuticals, chemical process design, telecommunications and mobile phones.

Charlotte May is a barrister at 8 New Square. She was appointed as Standing Counsel to the Comptroller General of Patents and Trade Marks in December 2008, and has wide ranging experience in SPC related disputes in both the UK courts and the ECJ including Generics v Synaptech and Astellas Pharma Inc v Comptroller-General of Patents.

Sebastian Moore is a Partner in Intellectual Property at Herbert Smith. As well as running large multi-jurisdictional pharmaceutical patent actions (including the first streamlined patent action to come to trial), he has advised a number of pharmaceutical and biotechnology companies on licensing and freedom to operate issues. He is a guest lecturer at the University of London and a tutor on the Oxford University Diploma in Intellectual Property Law and Practice.

Jonathan Turnbull is an Associate in Herbert Smith's Intellectual Property Team

Gordon Wright is a Partner at Elkington and Fife LLP. Having worked over 20 years in the pharmaceutical industry, most recently as Head of Intellectual Property for Sanofi- Synthelabo in France, Gordon Wright handles mainly chemical and pharmaceutical subject matter. Gordon has an in-depth knowledge of IP topics specifically related to the pharmaceutical industry, including in particular supplementary protection certificates (SPCs), regulatory data exclusivity, product life cycle management, pharmaceutical trade marks, parallel imports and arrangements, often taking a key part in structuring the deal and drafting the agreements.